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ASCO and IOM Convene Workshop on Implementing a National Cancer Clinical Trials System for the 21st Century

Mar 28, 2011

April 2011: To promote a collaborative approach to implementing the 2010 IOM report on restructuring the Cooperative Group Program, the National Cancer Institute (NCI), Cooperative Group leadership, insurers, industry, the Food and Drug Administration (FDA), investigators, and patient advocates participated in a workshop, sponsored by ASCO and the Institute of Medicine (IOM) on March 21. ASCO President George W. Sledge, Jr., MD, stated, “ASCO is working to propel the IOM’s call to ‘reinvigorate’ the Cooperative Group system because we rely on its research findings to improve care for current and future cancer patients.”

National Cancer Institute and the Cooperative Groups
The first workshop panel included representatives of NCI as well as the chair and biostatistician for most of the ten Cooperative Groups. NCI outlined its plans to issue a funding opportunity announcement in 2012 to support a total of four adult, multi-disease cooperative groups and one pediatric group to participate in a national clinical trials system. The Group representatives highlighted alliances already underway, including planned mergers between CALGB, NCCTG, and ACOSOG; RTOG and NSABP; and ECOG and ACRIN. The Groups also discussed collaborations between the Groups and other NCI-funded mechanisms (e.g., RO1 investigators, cancer centers, and SPOREs) and the need for both incentives and education about the value of increased collaborations. NCI and the Groups talked about improvements already made to speed the concept and protocol review process, and NCI discussed creating a new cross-disease panel to develop extramural feedback to establish clear priorities for the entire portfolio of NCI-funded clinical trials. Panelists also stressed the need to provide funding to adequately compensate the cost of conducting trials.

Health Care Payers
A payer/insurer panel highlighted the differing policies among private payers and Medicare regarding coverage of clinical trials. Data from a Johns Hopkins University study demonstrated these differences and highlighted the importance of insurer coverage of routine expenses to promote clinical trial accrual. James Cross, MD, representing Aetna mentioned that payer coverage policies can serve to increase participation in clinical trials, thereby developing the evidence insurers need to make coverage decisions. Even within a company, coverage policies vary regionally due to differing state laws and cooperative coverage agreements, as well as circumstances where the insurer is merely administrating an employer-insured plan. Karen Hagerty, MD, ASCO Director of Reimbursement Policy also discussed the process for implementing the IOM Report recommendation of developing a CPT code for enhanced reimbursement for offering, enrolling, managing, and following a patient on a clinical trial. Panelists acknowledged that a code would provide improved granularity and certainty about the services that are being covered, and that it could ultimately result in more appropriate reimbursement.

Industry and Other Federal Agencies
As noted by members of this panel, there is a long history of collaboration between industry and the Cooperative Groups. These partnerships have led to practice-changing outcomes and have been bolstered by the Cooperative Groups’ access to large numbers of patients and world-renowned investigators. However, panelists acknowledged that collaboration with the Cooperative Groups can be unattractive to industry because of potential delays in initiating trials and non-standardized mechanisms for collecting and reporting data. The panelists were hopeful that restructuring the federally-funded system and creating uniform processes across the system will improve partnership opportunities. Jerry Menikoff, MD, JD, Director of HHS Office for Human Research Protection (OHRP), said that the Office has been encouraging the use of centralized institutional review boards (IRB) because of their potential to improve ethical review across multi-center trials. Members of the audience encouraged OHRP to issue more definitive guidance to address institutional concerns without relying on an outside IRB. Other panel topics included improvements to informed consent documents, the need for more informative biomarkers, and improved information technology systems for data collection. Richard Pazdur, MD, Director of the FDA Office of Oncology Drug Products, encouraged the audience to identify areas where Cooperative Group trials play an important role and shared some previously developed guiding principles as a starting point for collaborations between the Groups and industry.

Investigators and Patient Advocates
The final panel focused on the perspective of clinical trials investigators and Cooperative Group advocates regarding the reorganization of the Cooperative Groups. The discussion focused on ways to keep investigators engaged in the Cooperative Group process, the need to identify acceptable outcomes and clear metrics for success, the benefits and challenges of an open clinical trials system where any NCI investigator can accrue patients to any trial, and incentives to promote collaboration between community and academic centers. The panel also discussed the importance of developing the same accountability and metrics for other NCI programs that conduct clinical trials.

In his closing remarks, workshop chairman Richard L. Schilsky, MD, echoed the IOM report’s conclusion that “it is imperative to preserve and strengthen the unique capabilities of the Cooperative Group Program as a vital component in NCI’s translational continuum.” While numerous reports have been issued on the Group system, the entire community is responding in significant ways to address the critical challenges that plague the system. ASCO is developing a checklist of the IOM recommendations and stakeholder response that it will release in the coming weeks. Dr. Sledge noted that “IOM and ASCO plan to reconvene a workshop in 2012, and ASCO will be working with stakeholders throughout the community in the interim to ensure that we have positive news to report on improvements we are making to the system.” Presentations from the workshop are available on the IOM website.

This article was first published in the ASCO in Action Brief.


Exemplary Attributes
The latest articles in the Journal of Oncology Practice (JOP) series on attributes of exemplary clinical research sites focus on implementing clinical trials and investigator responsibilities. Visit jop.ascopubs.org and select “Attributes of Exemplary Research” under the Browse by Topic section to read the entire series for free.


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